Bioanalytical validation method for capmatinib and spartalizumab in rabbit plasma by using highly effective mass spectrophotometric method

LC-MS was developed and verified as a quick, sensitive, and easy approach for the simultaneous measurement of Capmatinib and Spartalizumab. C18 column separation was carried out (150 x 4.6 mm, 3.5) using isocratic elution with a buffer made of 1 mL of formic acid in 1 lit of water and a mixture of two components, such as buffer and acetonitrile, in a 50:50 ratio, with a flow rate of 1 mL/min and room temperature as the mobile phase. In less than eight minutes, the analysis was completed. For Capmatinib and Spartalizumab, within the concentration range of 1.0 ng/mL to 20 ng/mL, the calibration curve was linear. (r2 = 0.999 and 0.99, respectively). All of the system appropriateness, specificity, linearity, and accuracy characteristics are successfully utilized for the analysis of rabbit pharmacokinetic studies and are in good accordance with USFDA recommendations.